Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ongoing, recruiting
Participants planned
642
Countries
9
Sites
51
Relapsed/refractory multiple myeloma in patients who have received 1 to 3 prior lines of therapy and have been exposed to both an immunomodulatory drug and an anti-CD38 monoclonal antibody
To compare the efficacy of anitocabtagene autoleucel versus standard of care therapy (SOCT) in participants with RRMM
Key facts
- Sponsor
- Kite Pharma Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 20 Dec 2024 → ongoing
- Decision date (initial)
- 2024-12-15
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- Yes
- Funding sources
- Kite Pharma Inc.
External identifiers
- EU CT number
- 2024-511188-26-00
- ClinicalTrials.gov
- NCT06413498
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Pharmacokinetic, Safety, Therapy, Pharmacogenomic, Pharmacodynamic, Pharmacogenetic, Efficacy
To compare the efficacy of anitocabtagene autoleucel versus standard of care therapy (SOCT) in participants with RRMM
Secondary objectives 4
- To further characterize the efficacy profile of anitocabtagene autoleucel
- To further characterize the safety profile of anitocabtagene autoleucel
- To assess patient-reported outcomes (PROs) associated with anitocabtagene autoleucel compared with SOCT
- To measure healthcare resource utilization
Conditions and MedDRA coding
Relapsed/refractory multiple myeloma in patients who have received 1 to 3 prior lines of therapy and have been exposed to both an immunomodulatory drug and an anti-CD38 monoclonal antibody
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 25.0 | LLT | 10086466 | Relapsed/refractory multiple myeloma | 100000004848 |
Regulatory references
- Scientific advice from competent authorities
- European Medicines Agency, Food And Drug Administration, Paul-Ehrlich-Institut
- Plan to share IPD
- No
- IPD plan description
- No
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 8
- Documented historical diagnosis of MM
- Received 1 to 3 prior lines of antimyeloma therapy, including an IMiD and an anti-CD38 mAb. A minimum of 2 consecutive cycles of an IMiD and an anti-CD38 mAb in any prior line of therapy is required. The IMiD and anti-CD38 mAb do not need to be from the same regimen in the prior line(s) of therapy.
- Documented evidence of progressive disease by IMWG criteria based on the investigator’s determination on or within 12 months of the last dose of the last regimen
- Measurable disease at screening per IMWG, defined as any of the following: a) Serum M-protein level ≥ 0.5 g/dL or urine M-protein level ≥ 200 mg/24 hours; or b) Light chain MM without measurable disease in the serum or urine: serum free light chain ≥ 10 mg/dL and abnormal serum free light chain ratio
- Only participants who are candidates to receive at least 1 of the 4 SOCT regimens (PVd, DPd, KDd, or Kd), as determined by the investigator, should be considered for this Study
- Male or female aged 18 years or older and who have provided written informed consent
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Females of childbearing potential must have a medically supervised negative serum or urine pregnancy test with a sensitivity of at least 25 mIU/mL (females who have undergone surgical sterilization or who have been postmenopausal for at least 2 years are not considered to be of childbearing potential)
Exclusion criteria 14
- Prior BCMA-targeted therapy
- Prior T-cell engager therapy
- Prior CAR therapy or other genetically modified T-cell therapy
- Active or prior history of central nervous system (CNS) or meningeal involvement of MM
- Cardiac atrial or cardiac ventricular MM involvement
- History of or active plasma cell leukemia (defined as 5% circulating plasma cells per IMWG 2021 consensus definition , Waldenstrom’s macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes), or amyloidosis
- Active malignancy (other than MM) requiring ongoing treatment for disease control within the last 24 months. Myelodysplastic syndrome (even without ongoing treatment) is not permitted.
- Prior auto-SCT within 12 weeks before randomization
- Prior allogeneic stem cell transplant (allo-SCT)
- High-dose (eg, cumulative > 70 mg prednisone or equivalent) systemic steroid therapy or any other form of immunosuppressive therapy within 14 days before randomization
- Live vaccine ≤ 4 weeks before randomization
- Contraindication to fludarabine or cyclophosphamide
- History of allergy or hypersensitivity to any study agent or study drug components. Participants with a history of severe hypersensitivity reaction including anaphylaxis due to dimethyl sulfoxide (DMSO) or gentamicin are excluded.
- Life expectancy < 12 weeks
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 2
- PFS, defined as the time to disease progression per IMWG criteria as determined by IRC, or death due to any cause, whichever occurs first
- Minimal residual disease (MRD)-negative complete response (CR) rate at 9 months, defined as the proportion of participants achieving CR/stringent CR (sCR) and MRD-negative status at 9 months. MRD negativity at 9 months is defined as negative MRD value at 9 months (± 3 months) in bone marrow assessment (< 1 in 105 nucleated cells per IMWG criteria using NGS) {Kumar 2016}. CR/sCR per IMWG criteria is determined by IRC
Secondary endpoints 14
- Complete response (CR) rate (CR/stringent CR [sCR]) per IMWG criteria by IRC
- Overall minimal residual disease (MRD) negativity (minimum 10^−5)
- Overall survival (OS)
- Overall response rate
- MRD-negative CR/sCR and MRD-negative very good partial response (VGPR)+
- Sustained MRD negativity
- Duration of response
- Time to progression
- Time to next treatment
- Incidence, seriousness, and severity of all adverse events (AEs)
- Levels of anti-anitocabtagene autoleucel chimeric antigen receptor (CAR) antibodies (anitocabtagene autoleucel arm)
- Presence of replication-competent lentivirus (RCL) (anitocabtagene autoleucel arm)
- Change from baseline quality of life scores across postbaseline assessment visits as measured by: European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30). European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire – Multiple Myeloma Module (EORTC QLQ-MY20). European Quality of Life 5-Dimension 5-Level Scale (EQ-5D-5L)
- Frequency of hospitalizations, inpatient days, intensive care unit days, and reasons for hospitalization
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PRD11373338 · Product
- Active substance
- Anitocabtagene Autoleucel
- Substance synonyms
- KITE-772, CART-ddBCMA
- Pharmaceutical form
- DISPERSION FOR INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 00 DF dosage form
- Max total dose
- 00 DF dosage form
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- KITE PHARMA INC.
- Paediatric formulation
- No
- Orphan designation
- No
Comparator 14
Bortezomib Fresenius Kabi 2.5 mg powder for solution for injection
PRD8441400 · Product
- Active substance
- Bortezomib
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 00 mg/m2 milligram(s)/sq. meter
- Max total dose
- 00 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 13 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01XG01 — -
- Marketing authorisation
- EU/1/19/1397/003
- MA holder
- FRESENIUS KABI DEUTSCHLAND GMBH
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Bortezomib Fresenius Kabi 3.5 mg powder for solution for injection
PRD7748377 · Product
- Active substance
- Bortezomib
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 00 mg/m2 milligram(s)/sq. meter
- Max total dose
- 00 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 13 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01XG01 — -
- Marketing authorisation
- EU/1/19/1397/001
- MA holder
- FRESENIUS KABI DEUTSCHLAND GMBH
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Bortezomib Fresenius Kabi 1 mg powder for solution for injection
PRD8441396 · Product
- Active substance
- Bortezomib
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 00 mg/m2 milligram(s)/sq. meter
- Max total dose
- 00 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 13 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01XG01 — -
- Marketing authorisation
- EU/1/19/1397/002
- MA holder
- FRESENIUS KABI DEUTSCHLAND GMBH
- MA country
- Liechtenstein
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Kyprolis 30 mg powder for solution for infusion
PRD4301210 · Product
- Active substance
- Carfilzomib
- Substance synonyms
- PR-171
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 00 mg/m2 milligram(s)/sq. meter
- Max total dose
- 00 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 236 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01XG02 — -
- Marketing authorisation
- EU/1/15/1060/003
- MA holder
- AMGEN EUROPE B.V.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- Yes
- Orphan designation number
- EU/3/08/548
- Modified vs. Marketing Authorisation
- No
Kyprolis 10 mg powder for solution for infusion
PRD4301209 · Product
- Active substance
- Carfilzomib
- Substance synonyms
- PR-171
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 00 mg/m2 milligram(s)/sq. meter
- Max total dose
- 00 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 236 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01XG02 — -
- Marketing authorisation
- EU/1/15/1060/002
- MA holder
- AMGEN EUROPE B.V.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- Yes
- Orphan designation number
- EU/3/08/548
- Modified vs. Marketing Authorisation
- No
Kyprolis 60 mg powder for solution for infusion
PRD3374183 · Product
- Active substance
- Carfilzomib
- Substance synonyms
- PR-171
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 00 mg/m2 milligram(s)/sq. meter
- Max total dose
- 00 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 236 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01XG02 — -
- Marketing authorisation
- EU/1/15/1060/001
- MA holder
- AMGEN EUROPE B.V.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- Yes
- Orphan designation number
- EU/3/08/548
- Modified vs. Marketing Authorisation
- No
PRD3861554 · Product
- Active substance
- Dexamethasone
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 00 mg milligram(s)
- Max total dose
- 00 mg milligram(s)
- Max treatment duration
- 236 Week(s)
- Authorisation status
- Authorised
- ATC code
- H02AB02 — DEXAMETHASONE
- Marketing authorisation
- EU/1/15/1053/001
- MA holder
- THERAVIA
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
DARZALEX 20 mg/mL concentrate for solution for infusion
PRD4091122 · Product
- Active substance
- Daratumumab
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 00 mg/kg milligram(s)/kilogram
- Max total dose
- 00 mg/kg milligram(s)/kilogram
- Max treatment duration
- 236 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01FC01 — -
- Marketing authorisation
- EU/1/16/1101/002
- MA holder
- JANSSEN-CILAG INTERNATIONAL NV
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- Yes
- Orphan designation number
- EU/3/13/1153
- Modified vs. Marketing Authorisation
- No
DARZALEX 20 mg/mL concentrate for solution for infusion
PRD4091129 · Product
- Active substance
- Daratumumab
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 00 mg/kg milligram(s)/kilogram
- Max total dose
- 00 mg/kg milligram(s)/kilogram
- Max treatment duration
- 236 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01FC01 — -
- Marketing authorisation
- EU/1/16/1101/001
- MA holder
- JANSSEN-CILAG INTERNATIONAL NV
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- Yes
- Orphan designation number
- EU/3/13/1153
- Modified vs. Marketing Authorisation
- No
DARZALEX 20 mg/mL concentrate for solution for infusion
PRD6808129 · Product
- Active substance
- Daratumumab
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 00 mg/kg milligram(s)/kilogram
- Max total dose
- 00 mg/kg milligram(s)/kilogram
- Max treatment duration
- 236 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01FC01 — -
- Marketing authorisation
- EU/1/16/1101/003
- MA holder
- JANSSEN-CILAG INTERNATIONAL NV
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- Yes
- Orphan designation number
- EU/3/13/1153
- Modified vs. Marketing Authorisation
- No
PRD9260806 · Product
- Active substance
- Pomalidomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 00 mg milligram(s)
- Max total dose
- 00 mg milligram(s)
- Max treatment duration
- 17 Month(s)
- Authorisation status
- Authorised
- ATC code
- L04AX06 — -
- Marketing authorisation
- EU/1/13/850/003
- MA holder
- BRISTOL-MYERS SQUIBB PHARMA EEIG
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD9260804 · Product
- Active substance
- Pomalidomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 00 mg milligram(s)
- Max total dose
- 00 mg milligram(s)
- Max treatment duration
- 17 Month(s)
- Authorisation status
- Authorised
- ATC code
- L04AX06 — -
- Marketing authorisation
- EU/1/13/850/001
- MA holder
- BRISTOL-MYERS SQUIBB PHARMA EEIG
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD9260805 · Product
- Active substance
- Pomalidomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 00 mg milligram(s)
- Max total dose
- 00 mg milligram(s)
- Max treatment duration
- 17 Month(s)
- Authorisation status
- Authorised
- ATC code
- L04AX06 — -
- Marketing authorisation
- EU/1/13/850/002
- MA holder
- BRISTOL-MYERS SQUIBB PHARMA EEIG
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD9260808 · Product
- Active substance
- Pomalidomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 00 mg milligram(s)
- Max total dose
- 00 mg milligram(s)
- Max treatment duration
- 17 Month(s)
- Authorisation status
- Authorised
- ATC code
- L04AX06 — -
- Marketing authorisation
- EU/1/13/850/004
- MA holder
- BRISTOL-MYERS SQUIBB PHARMA EEIG
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Kite Pharma Inc.
- Sponsor organisation
- Kite Pharma Inc.
- Address
- 2400 Broadway
- City
- Santa Monica
- Postcode
- 90404-3030
- Country
- United States
Scientific contact point
- Organisation
- Kite Pharma Inc.
- Contact name
- EU CT Support
Public contact point
- Organisation
- Kite Pharma Inc.
- Contact name
- EU CT Support
Third parties 4
| Organisation | City, country | Duties |
|---|---|---|
| PPD Development LP ORL-000009382
|
United States | Other |
| Signant Health Global LLC ORG-100040604
|
Blue Bell, United States | Other |
| Labcorp Central Laboratory Services SARL ORG-100011524
|
Meyrin, Switzerland | Other |
| Medidata ORL-000009380
|
San Francisco, United States | Other, E-data capture |
Locations
9 EU/EEA countries · 51 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Austria | Ongoing, recruitment ended | 16 | 4 |
| Belgium | Ongoing, recruitment ended | 16 | 4 |
| Czechia | Ongoing, recruitment ended | 8 | 2 |
| France | Ongoing, recruitment ended | 40 | 10 |
| Germany | Ongoing, recruiting | 24 | 8 |
| Italy | Ongoing, recruitment ended | 20 | 5 |
| Netherlands | Ongoing, recruitment ended | 12 | 3 |
| Poland | Ongoing, recruitment ended | 16 | 4 |
| Spain | Ongoing, recruitment ended | 40 | 11 |
| Rest of world
Japan, United States, Canada, Australia, United Kingdom, Switzerland
|
— | 450 | — |
Investigational sites
Medical University Of Vienna
Universitätsklinik für Innere Medizin I, Klinische Abteilung für Hämatologie und Hämostaseologie, Waehringer Guertel 18-20, Alsergrund, Vienna
Ordensklinikum Linz GmbH
Hämatologie mit Stammzelltransplantation, Hämostaseologie und medizinische Onkologie, Fadingerstrasse 1, 4020, Linz
SCRI CCCIT Ges.m.b.H.
Uniklinikum Salzburg, Universitätsklinik für Innere Medizin III der PMU, Muellner Hauptstrasse 48, 5020, Salzburg
Noe LGA Gesundheit Region Mitte GmbH
Klinische Abteilung für Innere Medizin 1, Hämatoonkologie, Dunant-Platz 1, 3100, St. Poelten
Cliniques Universitaires Saint-Luc
Hematology Department, Hippokrateslaan 10, Batiment 54, Sint-Lambrechts-Woluwe
Antwerp University Hospital
Hematology Department, Drie Eikenstraat 655, 2650, Edegem
Universitair Ziekenhuis Gent
Hematology Department, Corneel Heymanslaan 10, 9000, Gent
UZ Leuven
Hematology Department, Herestraat 49, 3000, Leuven
Fakultni Nemocnice Brno
Interní hematologická a onkologická klinika, Jihlavska 340/20, Bohunice, Brno
Fakultni Nemocnice Ostrava
Klinika hematoonkologie, 17. Listopadu 1790/5, Poruba, Ostrava
Centre Hospitalier Universitaire De Lille
Service des Maladies du sang, Rue Michel Polonovski, 59037, Lille Cedex
Hospices Civils De Lyon
Service d’Hématologie, 165 Chemin Du Grand Revoyet, 69310, Pierre Benite
Centre Hospitalier Universitaire De Nantes
Service d’Hématologie Clinque, 1 Place Alexis Ricordeau, 44000, Nantes
Centre Hospitalier Universitaire De Montpellier
Service d’Hématologie clinique, 80 Avenue Augustin Fliche, 34295, Montpellier Cedex 5
Assistance Publique Hopitaux De Paris
Département de Thérapie Cellulaire et Hématologie Clinique, 184 Rue Du Faubourg Saint Antoine, 75012, Paris
Centre Hospitalier Universitaire De Toulouse
Service d‘Hématologie, 1 Avenue Irene Joliot Curie, 31059, Toulouse Cedex 9
Centre Hospitalier Universitaire De Rennes
Service d’Hématologie, 2 Rue Henri Le Guilloux, 35000, Rennes
Assistance Publique Hopitaux De Paris
Service d’Immuno-Hématologie, 1 Avenue Claude Vellefaux, 75010, Paris
Institut Paoli Calmettes
Service d’Hématologie, 232 Boulevard De Sainte Marguerite, Bp 156, Marseille
Centre Hospitalier Universitaire De Poitiers
Service d’Hématologie et Thérapie Cellulaire, 2 Rue De La Miletrie, 86000, Poitiers
University Medical Center Hamburg-Eppendorf
II. Medizinische Klinik und Poliklinik, Martinistrasse 52, Eppendorf, Hamburg
Universitaet Leipzig
Klinik und Poliklinik für Hämatologie, Zelltherapie, Hämostaseologie und Infektiologie, Studieneinh, Liebigstrasse 22a, Zentrum-Suedost, Leipzig
Charite Universitaetsmedizin Berlin KöR
Campus Benjamin Franklin (CBF) Med. Klinik m. Schwerpunkt Hämatologie, Onkologie u. Tumorimmunologie, Hindenburgdamm 30, Lichterfelde, Berlin
Klinikum rechts der Isar der TU Muenchen AöR
Klinik und Poliklinik für Innere Medizin III, Hämatologie/Onkologie, Ismaninger Strasse 22, Au-Haidhausen, Munich
Universitaetsklinikum Wuerzburg AöR
Medizinische Klinik und Poliklinik II, Oberduerrbacher Strasse 6, Grombuehl, Wuerzburg
Universitaetsklinikum Essen AöR
Klinik für Hämatologie und Stammzelltransplantation Westdeutsches Tumorzentrum Essen, Hufelandstrasse 55, Holsterhausen, Essen
University Hospital Cologne AöR
Klinik für Innere Medizin I, Kerpener Strasse 62, Lindenthal, Cologne
Medical Center - University Of Freiburg
Klinik für Innere Medizin I, ITZ, Schwerpunkt Hämatologie, Onkologie und Stammzelltransplantation, Hugstetter Strasse 55, Stuehlinger, Freiburg Im Breisgau
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Servizio e DH di Ematologia e Trapianto di cellule staminali, Largo Francesco Vito 1, 00168, Rome
Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
SC Ematologia U, Corso Bramante 88, 10126, Turin
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
UOC Ematologia, Via Pietro Albertoni 15, 40138, Bologna
Fondazione IRCCS Istituto Nazionale Dei Tumori
S.C. Ematologia – Trapianto di Midollo Osseo Allogenico, Via Giacomo Venezian 1, 20133, Milan
Ospedale San Raffaele S.r.l.
UOE-TMO, Via Olgettina 60, 20132, Milan
Universitair Medisch Centrum Groningen
Hematology, Hanzeplein 1, 9713 GZ, Groningen
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Hematology, Dr. Molewaterplein 40, 3015 GD, Rotterdam
Stichting Amsterdam UMC
Hematology, De Boelelaan 1117, 1081 HV, Amsterdam
Uniwersytecki Szpital Kliniczny Im. Jana Mikulicza-Radeckiego We Wroclawiu
Klinika Hematologii, Terapii Komórkowych i Chorób Wewnętrznych, Ul. Wybrzeze Ludwika Pasteura 4, 50-367, Wroclaw
Instytut Hematologii I Transfuzjologii
n/a, Ul Indiry Gandhi 14, 02-776, Warsaw
Uniwersytecki Szpital Kliniczny W Poznaniu
n/a, Ul. Augustyna Szamarzewskiego 84, 60-569, Poznan
Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego
Centralny Szpital Kliniczny, Klinika Hematologii, Transplantologii i Chorób Wewnętrznych, Ul. Ulica Stefana Banacha 1a, 02-097, Warsaw
Hospital Universitario 12 De Octubre
Hematology, Bloque D, Avenida De Cordoba Sn, Madrid
University Clinical Hospital Virgen De La Arrixaca
Hematology, Carretera Madrid-Cartagena S/N, El Palmar, Murcia
Hospital Universitario Ramon Y Cajal
Hematology, Carretera Del Colmenar Viejo Km 9 100, Por El Pardo, Madrid
University Hospital Virgen Del Rocio S.L.
Hematology, Avenida De Manuel Siurot S/n, 41013, Sevilla
Clinica Universidad De Navarra
Hematology, Pio XII Etorbidea 36, 31008, Pamplona
Hospital Universitario Marques De Valdecilla
Hematology, Avenida Valdecilla Sn, 39008, Santander
Hospital Clinic De Barcelona
Hematology, Calle Villarroel 170, 08036, Barcelona
Hospital Universitario De Salamanca
Hematology, Paseo De San Vicente 58-182, 37007, Salamanca
Institut Catala D'oncologia
Hematology, Carretera Canyet S/n, 08916, Badalona
Hospital Universitario Y Politecnico La Fe
Hematology, Avenida De Fernando Abril Martorell 106, 46026, Valencia
Institut Catala D'oncologia
Hematology, Avinguda De La Gran Via De L'hospitalet 199-203, 08908, L'hospitalet De Llobregat
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Austria | 2025-02-12 | 2025-03-26 | 2026-03-19 | ||
| Belgium | 2025-03-18 | 2025-03-18 | 2026-03-19 | ||
| Czechia | 2025-10-30 | 2026-01-15 | 2026-03-19 | ||
| France | 2025-02-14 | 2025-04-08 | 2026-03-19 | ||
| Germany | 2025-06-13 | 2025-06-26 | |||
| Italy | 2025-03-31 | 2025-04-29 | 2026-03-19 | ||
| Netherlands | 2025-05-08 | 2025-06-23 | 2026-04-08 | ||
| Poland | 2025-07-22 | 2025-10-13 | 2026-04-01 | ||
| Spain | 2024-12-20 | 2025-01-22 | 2026-03-19 |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Corrective measures 2 · Art. 77 CTR
Corrective measure CM-IT-0001
- Member state
- Italy
- Publication date
- 2025-07-28
- Type
- 1
- Reason
- 6
- Reverted date
- 2025-07-28
- Immediate action required
- Yes
- Notes
- Reverted (2025-07-28)
- Justification
- Dear Applicant,
Considering the expiration of the three-year mandate of the members of the National Ethics Committee (CEN) for clinical trials relating to advanced therapies (“ATMP”) and of the National Ethics Committee (CEN) for clinical trials in the pediatric field, appointed by Decree of the Minister of Health - 2 March 2022;
Considering the fact that, due to the expiration of the mandate of the members of the aforementioned National Ethics Committee (CEN), for the procedure in subject the assessment of the aspects relating to Part II of the evaluation report pursuant to art. 7 of the aforementioned Regulation (EU) No. 536/2014 has not been carried out, and as a result there is no conclusion of Part II for the EU CT 2024-511188-26-00 procedure (AIFA authorization provision n° 0058375-14/05/2025-AIFA-AIFA_USC-P);
In compliance with CHAPTER XIII (SUPERVISION BY MEMBER STATES, UNION INSPECTIONS AND CONTROLS) of Regulation 536/2014 with specific reference to Article 77 (Corrective measures to be taken by Member States):
1. Where a Member State concerned has justified grounds for considering that the requirements set out in this Regulation are no longer met, it may take the following measures on its territory:
(a) revoke the authorisation of a clinical trial;
(b) suspend a clinical trial;
(c) require the sponsor to modify any aspect of the clinical trial.
A corrective measure is applied suspending the trial. This corrective measure is only applicable to Italy.
Corrective measure CM-IT-0002
- Member state
- Italy
- Publication date
- 2025-09-25
- Type
- 1
- Reason
- 6
- Reverted date
- 2025-09-25
- Immediate action required
- Yes
- Notes
- Reverted (2025-09-25)
- Justification
- Dear Applicant,
It was ascertained that the National Ethics Committee (CEN) due to technical issue did not assess the documentation submitted for the SM-2 EU CT 2024-511188-26-00 procedure (AIFA authorization provision n° 0114321-11/09/2025-AIFA-AIFA_USC-P).
Therefore, in compliance with CHAPTER XIII (SUPERVISION BY MEMBER STATES, UNION INSPECTIONS AND CONTROLS) of Regulation 536/2014 with specific reference to Article 77 (Corrective measures to be taken by Member States):
1. Where a Member State concerned has justified grounds for considering that the requirements set out in this Regulation are no longer met, it may take the following measures on its territory:
(a) revoke the authorisation of a clinical trial;
(b) suspend a clinical trial;
(c) require the sponsor to modify any aspect of the clinical trial.
A corrective measure is applied suspending the trial. This corrective measure is only applicable to Italy.
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 119 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol_2024-511188-26_redacted | EU Amd 4.0 |
| Protocol (for publication) | D4_Patient facing document_questionnaire_CZ_EORTC QLQ-C30 | 3 |
| Protocol (for publication) | D4_Patient facing document_questionnaire_DE_EORTC QLQ-C30 | 3 |
| Protocol (for publication) | D4_Patient facing document_questionnaire_EORTC QLQ-C30_redacted | 3 |
| Protocol (for publication) | D4_Patient facing document_questionnaire_ES_EORTC QLQ-C30 | 3 |
| Protocol (for publication) | D4_Patient facing document_questionnaire_FR_EORTC QLQ-C30 | 3 |
| Protocol (for publication) | D4_Patient facing document_questionnaire_IT_EORTC QLQ-C30 | 3 |
| Protocol (for publication) | D4_Patient facing document_questionnaire_NL_EORTC QLQ-C30 | 3 |
| Protocol (for publication) | D4_Patient facing document_questionnaire_PL_EORTC QLQ-C30 | 3 |
| Protocol (for publication) | D4_Patient facing documents_questionnaire_CZ_EORTC QLQ_MY20 | 1 |
| Protocol (for publication) | D4_Patient facing documents_questionnaire_CZ_EQ 5D 5L Paper Self-Complete | 1.2 |
| Protocol (for publication) | D4_Patient facing documents_questionnaire_DE_EORTC QLQ_MY20 | 1 |
| Protocol (for publication) | D4_Patient facing documents_questionnaire_DE_EQ 5D 5L Paper Self-Complete | 1 |
| Protocol (for publication) | D4_Patient facing documents_questionnaire_EN_EQ 5D 5L Paper Self-Complete | 1.2 |
| Protocol (for publication) | D4_Patient facing documents_questionnaire_EORTC QLQ_MY20 redacted | 1 |
| Protocol (for publication) | D4_Patient facing documents_questionnaire_ES_EORTC QLQ_MY20 | 1 |
| Protocol (for publication) | D4_Patient facing documents_questionnaire_ES_EQ 5D 5L Paper Self-Complete | 1 |
| Protocol (for publication) | D4_Patient facing documents_questionnaire_FR_EORTC QLQ_MY20 | 1 |
| Protocol (for publication) | D4_Patient facing documents_questionnaire_FR_EQ 5D 5L Paper Self-Complete | 1.2 |
| Protocol (for publication) | D4_Patient facing documents_questionnaire_IT_EORTC QLQ_MY20 | 1 |
| Protocol (for publication) | D4_Patient facing documents_questionnaire_IT_EQ 5D 5L Paper Self-Complete | 1.1 |
| Protocol (for publication) | D4_Patient facing documents_questionnaire_NL_EORTC QLQ_MY20 | 1 |
| Protocol (for publication) | D4_Patient facing documents_questionnaire_NL_EQ 5D 5L Paper Self-Complete | 1.1 |
| Protocol (for publication) | D4_Patient facing documents_questionnaire_PL_EORTC QLQ_MY20 | 1 |
| Protocol (for publication) | D4_Patient facing documents_questionnaire_PL_EQ 5D 5L Paper Self-Complete | 1 |
| Recruitment arrangements (for publication) | K1_KT-US-679-0788_Addendum_to_Recruitment-Arrangements_DE_Public | 1.0 |
| Recruitment arrangements (for publication) | K1_KT-US-679-0788_Recruitment_Arrangements_FR_French | 2.0 |
| Recruitment arrangements (for publication) | K1_KT-US-679-0788_Recruitment_Informed-Consent-Procedure_CZ_Public | 2.0 |
| Recruitment arrangements (for publication) | K1_KT-US-679-0788_Recruitment-Arragements_PL_Polish_Public | 2.0 |
| Recruitment arrangements (for publication) | K1_KT-US-679-0788_Recruitment-Arrangements_AT_Public | 2.0 |
| Recruitment arrangements (for publication) | K1_KT-US-679-0788_Recruitment-Arrangements_BE_English_Public | 2.0 |
| Recruitment arrangements (for publication) | K1_KT-US-679-0788_Recruitment-Arrangements_DE_clean_Public | 2.0 |
| Recruitment arrangements (for publication) | K1_KT-US-679-0788_Recruitment-Arrangements_ES | 2 |
| Recruitment arrangements (for publication) | K1_KT-US-679-0788_Recruitment-Arrangements_IT_Italian_Public | 2.0 |
| Recruitment arrangements (for publication) | K1_KT-US-679-0788_Recruitment-arrangements_NL_English_Public | N/A |
| Recruitment arrangements (for publication) | K2_KT-US-679-0788_GP-Letter_IT_Italian_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_KT-US-679-0788_Patient Flyer_NL_Dutch_Public | N/A |
| Recruitment arrangements (for publication) | K2_KT-US-679-0788_Patient Flyer-BE-Dutch_Public | N/A |
| Recruitment arrangements (for publication) | K2_KT-US-679-0788_Patient Flyer-BE-English_Public | N/A |
| Recruitment arrangements (for publication) | K2_KT-US-679-0788_Patient Flyer-BE-French_Public | N/A |
| Recruitment arrangements (for publication) | K2_KT-US-679-0788_Patient_Flyer_FR_French_Public | n/a |
| Recruitment arrangements (for publication) | K2_KT-US-679-0788_Patient-Flyer_ES_Spanish_Public | N/A |
| Recruitment arrangements (for publication) | K2_KT-US-679-0788_Patient-Flyer_PL_Polish_Public | n/a |
| Recruitment arrangements (for publication) | K2_KT-US-679-0788_Patient-Recruitment-Flyer_AT_German_Public | n/a |
| Recruitment arrangements (for publication) | K2_KT-US-679-0788_Patient-Recruitment-Flyer_DE_German_Public | n/a |
| Recruitment arrangements (for publication) | K2_KT-US-679-0788_Patient-Recruitment-Flyer_IT_Italian_Public | n/a |
| Recruitment arrangements (for publication) | K2_KT-US-679-0788_Recruitment_Flyer_CZ_CS_Public | n/a |
| Subject information and informed consent form (for publication) | L1_KT-US-679-0788_FR-ICF_DE_German_clean_Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_KT-US-679-0788_GDPR ICF_CZ_Czech_CL_Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_KT-US-679-0788_Main ICF_CZ_Czech_CL_Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_KT-US-679-0788_Main ICF_FR_French_Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_KT-US-679-0788_Main_ICF_IT_Italian_Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_KT-US-679-0788_Main-ICF_AT_German_Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_KT-US-679-0788_Main-ICF_BE_Dutch_Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_KT-US-679-0788_Main-ICF_BE_English_Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_KT-US-679-0788_Main-ICF_BE_French_Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_KT-US-679-0788_Main-ICF_DE_German_clean_Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_KT-US-679-0788_Main-ICF_ES_Spanish_Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_KT-US-679-0788_Main-ICF_PL_Polish_Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_KT-US-679-0788_Optional Biopsy ICF_CZ_Czech_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_KT-US-679-0788_Optional Future Research ICF_CZ_Czech_CL_Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_KT-US-679-0788_Optional-FR-ICF_AT_German_Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_KT-US-679-0788_Optional-Future-Research_ICF_IT_Italian_Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_KT-US-679-0788_Participant-Pregnancy-Follow-Up-ICF_BE_Dutch_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_KT-US-679-0788_Participant-Pregnancy-Follow-Up-ICF_BE_English_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_KT-US-679-0788_Participant-Pregnancy-Follow-Up-ICF_BE_French_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_KT-US-679-0788_Partner-Pregnancy-Follow-Up-ICF_BE_Dutch_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_KT-US-679-0788_Partner-Pregnancy-Follow-Up-ICF_BE_English_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_KT-US-679-0788_Partner-Pregnancy-Follow-Up-ICF_BE_French_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_KT-US-679-0788_PP-Follow-Up-ICF_PL_Polish_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_KT-US-679-0788_Pregnancy Fup_ICF_FR_French_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_KT-US-679-0788_Pregnancy_ICF_IT_Italian_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_KT-US-679-0788_Pregnant Participant FUL_ ICF_CZ_Czech_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_KT-US-679-0788_Pregnant Partner FUL_ ICF_CZ_Czech_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_KT-US-679-0788_Pregnant-Participant_ICF_AT_German_clean_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_KT-US-679-0788_Pregnant-Participant-ICF_DE_German_clean_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_KT-US-679-0788_Pregnant-Partner_ICF_AT_German_clean_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_KT-US-679-0788_Pregnant-Partner-ICF_DE_German_clean_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_KT-US-679-0788_Pregnant-Partner-ICF_ES_Spanish_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_KT-US-679-0788_Privacy-Addendum_ICF_IT_Italian_Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_KT-US-679-0788_SC-Caregiver-ICF_DE_German_Clean_Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_KT-US-679-0788_SC-ICF_AT_German_Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_KT-US-679-0788_SC-ICF_PL_Polish_Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_KT-US-679-0788_SC-Patient-ICF_DE_German_clean_Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_KT-US-679-0788_SC-Telephone-Pre-ICF_AT_German_Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_KT-US-679-0788_SC-telephone-Pre-ICF_DE_German_clean_Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_KT-US-679-0788_Scout ICF_CZ_Czech_Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_KT-US-679-0788_Scout Telephone Data ICF_CZ_Czech_CL_Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_KT-US-679-0788_Scout_ICF_FR_French_Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_KT-US-679-0788_Scout-ICF_BE_Dutch_Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_KT-US-679-0788_Scout-ICF_BE_English_Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_KT-US-679-0788_Scout-ICF_BE_French_Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_KT-US-679-0788_Scout-ICF_ES_Spanish_Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_KT-US-679-0788_Scout-ICF_IT_Italian_Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_KT-US-679-0788_Scout-Pre-ICF-Telephone-Data-Consent_IT_Italian_Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_KT-US-679-0788_SIS-and_ICF-adults_NLD_nld_Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_KT-US-679-0788_SIS-and-ICF-Pregnancy_NL_Dutch_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_KT-US-679-0788_SIS-and-ICF-Scout_NL_Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_KT-US-679-0788_Telephone-Data-ICF_ES_Spanish_Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_KT-US-679-0788_Telephone-Data-ICF_PL_Polish_Public | 2.0 |
| Subject information and informed consent form (for publication) | L2_KT-US-679-0788_Patient-Card_DE_German_Public | 1.0.0 |
| Subject information and informed consent form (for publication) | L2_KT-US-679-0788_Scout-telephone-consent_NL_Public | 2.0 |
| Subject information and informed consent form (for publication) | L2_KT-US-679-0788_Site_Patient Advocacy_Contact List for ICF_AT_Public | n/a |
| Subject information and informed consent form (for publication) | L2_KT-US-679-0788_Table of Visists and Procedures_CZ_Czech_CL_Public | 3.0 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Bortezomib Fresenius Kabi 1 mg powder for solution for injection | 2 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Darzalex 20 mg mL concentrate for solution for infusion | 3 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Imnovid hard capsules | 2 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Kyprolis powder for solution for infusion | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Neofordex 40 mg tablets | 1 |
| Synopsis of the protocol (for publication) | D1_Plain Language Protocol Synopsis_NL_2024-511188-26 | Global 2.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_AT_2024-511188-26_redacted | Global 2.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_CZ_2024-511188-26_redacted | Global 2.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_DE_BE_2024-511188-26_redacted | Global 2.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_ES_2024-511188-26_redacted | Global 2.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_FR_2024-511188-26_redacted | Global 2.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_FR_BE_2024-511188-26_redacted | Global 2.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_IT_2024-511188-26_redacted | Global 2.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_NL_BE_2024-511188-26_redacted | Global 2.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_PL_2024-511188-26_redacted | Global 2.0 |
Application history
12 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-07-26 | Germany | Acceptable 2024-12-09
|
2024-12-09 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-12-18 | Acceptable 2024-12-09
|
2024-12-18 | |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2024-12-20 | Acceptable 2024-12-09
|
2024-12-20 | |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2025-01-02 | Germany | Acceptable 2024-12-09
|
2025-01-02 |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-4 | 2025-01-07 | Acceptable 2024-12-09
|
2025-01-07 | |
| 6 | NON SUBSTANTIAL MODIFICATION | NSM-5 | 2025-01-08 | Acceptable 2024-12-09
|
2025-01-08 | |
| 7 | NON SUBSTANTIAL MODIFICATION | NSM-6 | 2025-01-08 | Acceptable 2024-12-09
|
2025-01-08 | |
| 8 | NON SUBSTANTIAL MODIFICATION | NSM-7 | 2025-01-09 | Acceptable 2024-12-09
|
2025-01-09 | |
| 9 | NON SUBSTANTIAL MODIFICATION | NSM-8 | 2025-01-22 | Acceptable 2024-12-09
|
2025-01-22 | |
| 10 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-02-07 | Germany | Acceptable 2025-05-12
|
2025-05-13 |
| 11 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-06-18 | Germany | Acceptable 2025-09-08
|
2025-09-08 |
| 12 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-10-24 | Germany | Acceptable 2026-02-16
|
2026-02-16 |